A Study of Intermittent Oral Dosing of ASP1517 in ESA-untreated Chronic Kidney Disease Patients W… (NCT02964936) | Clinical Trial Compass
CompletedPhase 3
A Study of Intermittent Oral Dosing of ASP1517 in ESA-untreated Chronic Kidney Disease Patients With Anemia
Japan100 participantsStarted 2017-01-11
Plain-language summary
The objective of this study is to evaluate the efficacy and the safety when ASP1517 is intermittently administered in Erythropoiesis Stimulating Agent (ESA)-untreated non-dialysis chronic kidney disease patients with anemia.
Who can participate
Age range20 Years
SexALL
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Inclusion Criteria:
* Subjects who were diagnosed with non-dialysis chronic kidney disease (CKD) and who are considered not to require renal replacement therapy during the study period
* Mean of the subject's two most recent Hb values before randomization during the Screening Period must be \<10.5 g/dL with an absolute difference ≤1.3 g/dL between the two values
* Either transferrin saturation ≥ 5% or serum ferritin ≥ 30 ng/mL
* Female subject must either:
Be of non-childbearing potential:
* post-menopausal prior to pre-screening, or
* documented surgically sterile Or, if of childbearing potential,
* Agree not to try to become pregnant during the study after informed consent acquisition and for 28 days after the final study drug administration
* And have a negative urine pregnancy test at pre-screening
* And, if heterosexually active, agree to consistently use two forms of highly effective birth control (at least one of which must be a barrier method) starting at pre-screening and throughout the study period and for 28 days after the final study drug administration.
* Female subject must agree not to breastfeed starting at pre-screening and throughout the study period, and for 28 days after the final study drug administration.
* Female subject must not donate ova starting at pre-screening and throughout the study period, and for 28 days after the final study drug administration.
* Male subject and their female spouse/partners who are of childbearing potential must be using…
What they're measuring
1
Change from baseline in hemoglobin (Hb) response rate